Pharyngitis
Conditions
Brief summary
A study to in order to verify any differences between the 2 treatment groups in terms of duration of analgesic effects after the first drug intake and time to remission of symptoms and signs of pharyngitis
Interventions
DRUGBenzidamine hydrochloride
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male and female outpatients, aged 18 to 70 years, suffering from acute pharyngitis, pharyngolaryngitis * Moderately or severely intense pain in the pharyngeal region (score ≥ 70 mm) from the visual analogue scale (VAS) * At least 1 of the 2 inflammation signs (edema and hyperemia) to be moderately or severely intense (score ≥ 2) from the scoring scale from 0 to 3 * Release of written informed consent by the patient
Exclusion criteria
* Patients suffering from a microbial infection requiring specific antimicrobial treatment * Patients who have taken the trial drugs during the week before enrolment * Patients who have taken corticosteroids or antibiotics during the week before enrolment * Ascertained or suspected hypersensitivity to trial drugs or to chemically correlated drugs or to other non-steroidal anti-inflammatory drugs or to mouthwashes in general * Patients who are unable to properly fill in the diary every day as provided for by the protocol * Ascertained or presumed pregnant or lactating women * Inclusion in any other clinical trial during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of analgesic effects in hours | Up to 6 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average number of days required to obtain remission of pain | Up to day 8 | day on which 2 consecutive pain measurements are both below 10 mm of the visual analog scale (VAS) |
| Average severity of edema and hyperemia, assessed by investigator on a 4-point-scale | Up to day 8 | — |
Outcome results
None listed